Stent Benefit Questioned in Stable Disease

For patients with stable coronary artery disease, stent placement offers no more benefit than optimal medical therapy, according to a new meta-analysis.

by Michael Smith Michael Smith North American Correspondent, MedPage Today
February 28, 2012

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For patients with stable coronary artery disease (CAD), there's no benefit to receiving a stent compared with optimal medical therapy.

Stents also had no significant effect on the risk of nonfatal myocardial infarction, unplanned revascularization, or persistent angina.

For patients with stable coronary artery disease (CAD), stent placement offered no more benefit than optimal medical therapy, according to a new meta-analysis.

In clinical trials conducted in the era of modern medical treatment, stenting plus medical intervention did not significantly reduce the risk of death compared with medical intervention alone, according to Kathleen Stergiopoulos, MD, PhD, and David Brown, MD, of Stony Brook University Medical Center in Stony Brook, N.Y.

Stents also had no significant effect on the risk of nonfatal myocardial infarction, unplanned revascularization, or persistent angina, Stergiopoulos and Brown reported in the Feb. 27 issue of the Archives of Internal Medicine.

But the analysis was challenged by outside experts. Some said it adds nothing to current understanding of the issue, while others said it missed a clear benefit to patients for stenting.

And they contradict some earlier meta-analyses, which did find improvements in mortality and angina for patients assigned to undergo initial percutaneous coronary intervention (PCI).

But those analyses included older studies in which balloon angioplasty played a larger role in PCI and medical treatment was not as effective as it is now, Stergiopoulos and Brown argued.

The researchers included eight trials with a total of 7,229 patients, including the landmark COURAGE trial. For a study to be included, at last half of the patients assigned to PCI had to have been given a stent; the proportions ranged from 72% to 100%.

Taken together, the trials showed the death rate for stent implantation was 8.9% compared with 9.1% for medical therapy, yielding an odds ratio of 0.98 (95% CI 0.84 to 1.16).

The rates for nonfatal MI were also similar -- 8.9% for stents and 8.1% for medical therapy, yielding an OR of 1.12 (95% CI 0.93 to 1.34).

Also, the rate of unplanned revascularization in the stent group was 21.4%, compared with 30.7% in the medical treatment group (OR 0.78, 95% CI 0.57 to 1.06).

Finally, the rates of persistent angina were 29% for stents and 33% for medical therapy (OR 0.80, 95% CI 0.60 to 1.05).

The researchers argued that the continued use of stents in people with stable CAD is driven by the fee-for-service model and is markedly increasing healthcare costs.

They cautioned that the study is based on published results, because patient-level data were not available. And they noted that patients who take part in clinical trials may not be representative of those seen in general clinical practice.

Nevertheless, their results suggest that up to 76% of patients with stable CAD can avoid PCI altogether if treated with optimal medical therapy, they argued, adding that such an approach would result in "a lifetime savings of approximately $9,450 per patient in healthcare costs."

Indeed, many such procedures are not needed, and one study suggested that if one-third of elective PCI procedures in patients with stable disease could be averted or deferred, the associated cost savings would fall between $6 billion and $8 billion annually (Circ Cardiovasc Qual Outcomes 2009; 2: 134-140), commented William Boden, MD, of the Samuel S. Stratton VA Medical Center in Albany, N.Y.

In an accompanying comment article, Boden argued the "totality of evidence" doesn't support initial PCI in patients with stable CAD. "What more will it take to turn the tide of treatment?" he said.

But other clinicians were less enthusiastic about the Stergiopoulos and Brown analysis.

The study adds "nothing at all" to the debate, according to Kirk Garratt, MD, of Lenox Hill Hospital in New York City. In an email to MedPage Today/ABC News, Garratt said he and his colleagues use stenting in stable patients for "the improved functional capacity it offers," specifically a reduction in persistent angina.

He noted that the current analysis found about a 20% reduction in the rates of persistent angina and unplanned revascularization with stents -- similar to outcomes from other studies -- although the results did not reach statistical significance.

"This means stents can help get five more patients back to an active lifestyle, back to work, and closer to a normal life," he said.

Garratt added that the meta-analysis muddied the water by including three studies whose patients were stable after a previous MI, and these people form a "very different" patient population.

Jon Resar, MD, of Johns Hopkins University, concurred that the study adds little to what's known. "The premise that stenting patients with stable CAD decreases their chance of subsequent death or heart attack has not been thought to be valid for a long time," he said in an email to MedPage Today/ABC News.

On the other hand, he said, "there is indeed a significant minority of patients who undergo inappropriate coronary artery stenting," often because of financial incentives.

"Patients need to understand that simply putting in a stent in a blockage doesn't address the underlying problem," Resar said. "Lifestyle changes and aggressive medical management are far more important than just putting in a stent."

But that is easier said than done, according to David Fischman, MD, of Thomas Jefferson University in Philadelphia, who was one of the authors of a study that led to regulatory approval of stents.

"Patients have come to expect that if there is a coronary blockage, it needs to be fixed," he said in an email to MedPage Today/ABC News. "It is easier to fix a blockage than for a patient to lose the 40 pounds or to stop smoking."

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